Calculator How to use Theory & criteria
Free calculator · Method validation

Solution Stability Calculator

Find out how long your standard and sample solutions stay within the limit, from the % difference to the initial response.

  • Standard and sample
  • Stable-for result
  • Trend chart
  • No sign-up
How to use

Four steps, or fewer

  1. Set the allowed difference from the initial result.
  2. Paste the time points with the mean standard and sample responses. The first row is time zero.
  3. Read how long each solution is stable and use it in your method’s solution storage instructions.

Not sure what to enter? Press Load example to see the calculator with realistic data. Your inputs are saved in this browser, so they are still there when you come back.

Theory & criteria

How solution stability is assessed

% difference = (Aₜ − A₀) / A₀ × 100

A solution is considered stable up to the last time point before the difference first exceeds the limit. A limit of ±2.0% is common for assay solutions; impurity methods often use wider limits or look at changes in impurity levels.

References

  • ICH Q2(R2) Validation of analytical procedures
  • ICH Q14 Analytical procedure development

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These calculators are decision support for orientation and training. They are not validated GMP software, and results must be checked against your approved method, SOP and the current pharmacopoeia or guideline before use in GMP records. Your data is processed in your browser and is not sent to Molgenium.